Conduct Innovative Research on Hepatitis B Virus Cure

Through the Notice of Special Interest (NOSI): Towards Developing a Cure for HBV in HIV/HBV Co-Infection, NIAID invites investigator-initiated research project grant (R01, R21) and small business award (R41/R42, R43/R44) applications to perform innovative basic, translational, and clinical research to identify and address the unique challenges to achieving hepatitis B virus (HBV) cure in the presence of HIV.

The NOSI aims to inform HBV cure strategies by furthering our understanding of unique challenges impacting HBV and HIV co-infected hosts and advance discovery and development of novel HBV interventions that are safe and achieve a cure in co-infected individuals.

Key Research Topics

NIAID is especially interested in studies of HIV/HBV co-infection within the following disciplines:

Immunology

• Impact of HIV infection on HBV immune tolerance, immune activation/inflammation, and HBV viral persistence
• Factors critical to induce immune control of HBV

Virology

• Viral mechanisms and immune-related factors predictive of HBV reactivation
• Mechanism for cccDNA biogenesis and decay
• Role of integrated HBV DNA in HIV/HBV co-infection

Therapeutics and Diagnostics

• Blood-based biomarkers and non-invasive diagnostic tools as correlates to assess liver injury and indicators of treatment response
• In vitro animal models of infection for discovery and development of new agents
• Assessing valid endpoints in various phases of HBV infection to be applied in treatment studies of new therapeutics

Clinical trials are not allowed, although use of samples from clinical trials is allowed. Animal research is allowed, including projects involving nonhuman primates.

Do not propose a research project that focuses on hepatitis viruses other than HBV; focuses solely on HIV or HBV (rather than co-infection); or establishes new patient cohorts or adds patients to existing cohorts.

How To Apply

For this NOSI, you’ll apply through one of the following parent funding opportunity announcements (FOAs) or any subsequent reissued equivalent and write NOT-AI-22-043 in the Agency Routing Identifier field (box 4B) of the SF 424 R&R form.

• NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed)
• NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Not Allowed)
• Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR R43/R44, Clinical Trial Not Allowed)
• Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR R41/R42, Clinical Trial Not Allowed)

For limitations on budget amount, project period, and eligibility, as well as application submission deadlines, refer to the FOA through which you choose to apply. The first available due date for which you may apply is September 5, 2022.

Direct any questions to Dr. Chris Lambros, NIAID’s scientific/research contact for this initiative, at clambros@niaid.nih.gov or 240-627-3093.